Apparatus and method for compressing body tissue

ABSTRACT

A system and method for delivering a surgical clip to a surgical site within a patient&#39;s body to compress body tissue is disclosed. In one embodiment for the system of the present invention, the system includes an endoscopic device that has an endoscope cap disposed on a distal end of the endoscopic device. A surgical clip is removably disposed on an outside surface of the endoscope cap. A deployment device is associated with the surgical clip for deploying the surgical clip from the endoscope cap to the body tissue that is to be compressed. The surgical clip can be a deformable clip that is deployed in a non deformed configuration, and is then deformed so as to apply compression on selected tissue. The surgical clip can be a multi legged clip, having a plurality of legs that can be locked in a closed position to apply compression to body tissue.

RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 09/443,219 filed Nov. 18, 1999.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to an apparatus and method forcompressing body tissue to prevent hemorrhaging at a surgical sitewithin a patient's body. More specifically, the invention provides aclip and a system for delivering the clip to the surgical site. Thepresent invention could be utilized for any of a variety of procedures,including to close an organ perforation from inside a lumen byapproximating and compressing the wound edges of the perforated tissue.

2. Description of the Related Art

Bleeding Peptic Ulcer Disease can be a critical event since there isinternal hemorrhaging associated with the ulcer. Patients that aresuspected of having bleeding peptic ulcer disease can be diagnosed andtreated endoscopically in emergency rooms of medical centers, intensivecare units, or, in a Gastro-Intestinal (GI) suite, although personneland equipment may need to be transported to the patient. Surgery, eitherlaparoscopic or open, is an option. For example, if the diseased tissueis beyond repair, a surgical gastric resection may have to be performed.However, surgery is not preferred unless there is no endoscopicalternative or if previous endoscopic efforts have not succeeded.Surgical intervention is not preferred for at least the reasons that ithas associated with it greater morbidity and mortality, and also,significantly higher costs than other procedures.

Ulcers are classified from clean ulcer to active spurting bleeding. Themost worrisome are active bleeders and visible vessels. Untreatedvisible vessels are likely to bleed. For the GI endoscopist,hemorrhaging is the most worrisome procedure. It is his/her onlyunplanned, emergency procedure where time is critical in determining thesuccess or failure of the procedure. It is the one problem theendoscopist faces that is generally not an outpatient procedure.

The endoscopist generally has a primary success rate of about 90% intreating bleeding ulcers; the balance are usually referred to surgery.All identified ulcers may re-bleed at a later time, whetherendoscopically treated or untreated, but the re-bleed rate forendoscopically treated active bleeds and visible vessels is generally10-30%. These rates have not improved significantly in decades.

The long-term probability of success of surgery in treating a bleedingulcer, i.e., no re-bleed of the ulcer or permanent hemostasis, isvirtually 100%. The reason that surgery has a higher success rate isbecause the bleeding site is compressed mechanically. Using eithersutures or staples, the bleeding vessel is ligated, or tissue around thebleed site is compressed, ligating all of the surrounding vessels.

At present, the endoscopist has two widely used, and some lesser used(or experimental) therapeutic modalities for hemostasis. The most widelyused are thermal and injection therapy. Some of the lesser used optionsare a mechanical clip, a loop, lasers and argon plasma cautery. However,drawbacks exist with these known procedures for the endoscopist. A briefdescription of these procedures are provided below.

In thermal therapy, a catheter with a rigid, heating element tip ispassed through a working channel of an endoscope after the bleed isvisualized and diagnosed. After the rigid catheter tip has exited theendoscope, the endoscope is manipulated to press the tip against thebleed site. Thermal power is then applied which desiccates andcauterizes the tissue. The combination of the tip compressing thetissue/vessel during thermal application essentially (theoretically)welds the vessel closed. Thermal generation is accomplished by either aresistive element within the tip or by applying RF energy through thetissue. However, both methods require a specialized power generator.

For injection therapy, a catheter with a distally extendible hypo-needleis passed through a working channel of an endoscope after the bleed isvisualized and diagnosed. After the catheter tip has exited theendoscope, the endoscope is manipulated to the bleed site, the needle isextended remotely and inserted into the bleed site. A“vasoconstricting”, liquefied drug is remotely injected through theneedle. The drug constricts the vessels to stop the bleeding. The mostcommon drug is saline diluted epinephrine; alcohol is another option.This procedure usually requires that multiple injections be performedin, and peripherally around, the bleeding site until hemostasis isobserved.

Of the above two modalities, the preferred modality is dependent,generally, upon the geographic region in which it is performed.Different modalities are preferred in different geographic regions. Insome areas and institutions, both therapies are combined in an attemptto improve the outcome of the procedure.

For mechanical compression, loops and mechanical clips are known foruse, however, problems exist with each. A known loop is a snare-likeloop that is passed through an endoscope's working channel via aflexible delivery catheter. The loop is placed around the bleeding siteand retracted into the delivery catheter similar to the closing of asnare. The loop has a sliding member with a friction interface againstthe loop that acts like a draw string lock. After the loop is closed andlocked around the site, the assembly is unattached from the deliverycatheter. Whereas the loop is an endoscopically delivered compressiondevice, its primary use is for bleeding polyp stalks, and thus, it isnot designed for, nor appropriate for use in, ulcer treatmentprocedures. Specifically, the physical characteristics of an ulcer bed,such as its relatively flat geometry and the type of tissue comprisingthe ulcer bed, differ from those of a polyp such that the use of anendoscopically delivered loop for compression is inappropriate.

A mechanical clip is known, however, the known mechanical clip hasdrawbacks. The known clip is a two legged clip that is passed through anendoscope's working channel via a flexible delivery catheter. The jawsof the clip are remotely opened, pushed into the bleeding site, closedand detached. Because of the requirement to pass the clip through theendoscope, the clip's size must be limited which prevents the clip frombeing able to clamp off all of the vessels in the tissue around thewound. Additionally, the clip is not able to provide sufficient clampingforce because of its structural design. Thus, these clips requiremultiple applications and are not effective for definitive hemostasis.An additional problem with these clips is that when delivering theseclips to the wound site, good visualization of the bleeding vesselcannot be obtained. The endoscopist may be required to blindly attachthe clip, resulting in an imprecisely preformed procedure that mayrequire guess work on the part of the endoscopist.

Therefore, it would be desirable to provide an improved system andmethod for endoscopically treating bleeding ulcers which could bring theinitial hemostasis success rate for the endoscopic procedure in-linewith the success rate achievable in surgical procedures. This system andmethod would provide for an improved capability to mechanically compressthe bleeding site to achieve an effect which is commensurate with thatobtainable in a surgical procedure.

SUMMARY OF THE INVENTION

A system and method for delivering a surgical clip to a surgical sitewithin a patient's body to compress body tissue is provided. In oneembodiment for the system of the present invention, the system includesan endoscopic device that has an endoscope cap disposed on the distalend of the endoscopic device. A surgical clip is removably disposed onan outside surface of the endoscope cap. A deployment device isassociated with the surgical clip for deploying the surgical clip fromthe endoscope cap to the body tissue that is to be compressed.

The surgical clip can have various configurations. For example, thesurgical clip can be a substantially ring shaped clip that can bedeformed in a folded over configuration along diametrically opposedhinge points. Opposing edges of the surgical clip are thus folded one ontop of the other, and the body tissue can be compressed between thoseopposing edges.

Alternatively, the surgical clip can include a ring portion and movablelegs that can be placed in an open and a closed configuration. Themovable legs can be hinged to the ring portion and can include a fixingmechanism to keep the movable legs in the closed configuration,compressing the body tissue.

In one aspect the invention is a device for endoscopically deploying anhemostatic multi legged clip adapted to compress tissue that includes aring portion adapted to fit on a distal end of an endoscope, a pluralityof legs attached to the ring portion, each of the legs being movablebetween an open position and a closed position to compress tissue, and alocking mechanism to restrict movement of each of the legs from theclosed to the open position.

In another aspect, the invention is a device for endoscopicallydeploying an hemostatic clip adapted to grasp tissue in a deformedconfiguration. The device comprises a body adapted to fit on a distalend of an endoscope and to contain the clip, and a fulcrum portioncooperating with the body and the clip, the fulcrum portion having afirst position in contact with hinge points of the clip and a secondposition releasing the clip from the body. The device also includes anactuator exerting a force on push points of the clip to deform the clip,wherein, in the first position, the fulcrum portion retains the clipagainst the force exerted by the actuator to facilitate deformation ofthe clip.

BRIEF DESCRIPTION OF THE DRAWINGS

The various features of the invention will best be appreciated bysimultaneous reference to the description which follows and theaccompanying drawings, in which:

FIG. 1 is a perspective view of a first embodiment for a surgical clipin a tissue grasping position in accordance with the principles of thepresent invention;

FIG. 2 is a perspective view of the surgical clip of FIG. 1 with theclip in a tissue receiving position;

FIG. 3 is a perspective view of a first embodiment for a system fordelivering a surgical clip to a surgical site within a patient's body tocompress body tissue in accordance with the principles of the presentinvention;

FIG. 4 is a perspective view of the system of FIG. 3 with a firstembodiment of a deployment device for deploying the surgical clip fromthe endoscope cap;

FIG. 5 illustrates a second embodiment for a deployment device;

FIG. 6 illustrates a third embodiment for a deployment device and afirst embodiment for an intubation mechanism in accordance with theprinciples of the present invention;

FIG. 7 illustrates a fourth embodiment for a deployment device;

FIG. 8 is a cross-sectional view of the deployment device of FIG. 7;

FIG. 9 is a cross-sectional view of a fifth embodiment for a deploymentdevice;

FIG. 10 is a cross-sectional view of a sixth embodiment for a deploymentdevice;

FIG. 11 illustrates a first embodiment for a tissue grasping device inaccordance with the principles of the present invention;

FIG. 12 illustrates a second embodiment for a tissue grasping device;

FIG. 13 illustrates a third embodiment for a tissue grasping device asit is sequentially inserted into an organ wall;

FIG. 14 illustrates a second embodiment for an intubation mechanism;

FIG. 15 illustrates a third embodiment for an intubation mechanism;

FIG. 16 illustrates a fourth embodiment for an intubation mechanism;

FIG. 17 illustrates a second embodiment for a surgical clip thatincludes a different quantity of teeth than the embodiment illustratedin FIG. 1;

FIG. 18 illustrates a third embodiment for the surgical clip with thetissue grasping surfaces formed as straight members;

FIG. 19 illustrates a fourth embodiment for the surgical clip withenlarged joints;

FIG. 20 illustrates a fifth embodiment for the surgical clip withenlarged joints;

FIG. 21 illustrates a sixth embodiment for the surgical clip whichincludes additional structure at a center point of each joint;

FIG. 22 illustrates a seventh embodiment for the surgical clip whichincludes a torsion design for the first and second joints;

FIG. 23 illustrates an eighth embodiment for the surgical clip whichutilizes compression springs as the joints;

FIG. 24 illustrates a ninth embodiment for the surgical clip whichutilizes a spring as a component of the joints;

FIG. 25 illustrates a tenth embodiment for the surgical clip whichutilizes a torsion spring as a component of the joints;

FIG. 26 illustrates an eleventh embodiment for the surgical clip whichalso utilizes a torsion spring as a component of the joints;

FIG. 27 illustrates a twelfth embodiment for the surgical clip whichutilizes an elastomeric band as a component of the joints;

FIG. 28 illustrates a thirteenth embodiment for the surgical clip whichutilizes an elastomeric band as a component of the joints;

FIG. 29 illustrates a fourteenth embodiment for the surgical clip whichutilizes an elastomeric band as a component of the joints;

FIG. 30 illustrates a fifteenth embodiment for the surgical clip whichutilizes an elastomeric band as a component of the joints;

FIG. 31 illustrates a sixteenth embodiment for the surgical clip whichutilizes an elastomeric band as a component of the joints;

FIG. 32 illustrates a seventeenth embodiment for the surgical clip whichincludes a first embodiment for a lock to lock the first and secondtissue grasping surfaces in the tissue receiving position; and

FIG. 33 illustrates an eighteenth embodiment for the surgical clip whichincludes a second embodiment for a lock to lock the first and secondtissue grasping surfaces in the tissue receiving position.

FIG. 34 is an exploded view showing a different embodiment of theinvention, that includes a deformable surgical clip and elements todeform such surgical clip;

FIG. 35 is a perspective view showing an embodiment of the deformablesurgical clip in an undeformed configuration;

FIG. 36 is a perspective view showing the surgical clip of FIG. 35 in adeformed configuration;

FIG. 37 is a side view showing the embodiment of FIG. 34, with thesurgical clip in a non deformed configuration;

FIG. 38 is a side view of the embodiment of FIG. 37 with the surgicalclip in a deformed configuration;

FIG. 39 is a perspective view of the embodiment shown in FIG. 37, withthe deformed surgical clip being released;

FIG. 40 is a perspective view of one embodiment of the apparatus forinserting a deformable surgical clip;

FIG. 41 is a cross sectional view showing a second embodiment of thedevice for deploying deformable surgical clips;

FIG. 42 is a cross sectional view showing a third embodiment of thedevice for deploying deformable surgical clips;

FIG. 43 is a cross sectional view showing a fourth embodiment of thedevice for deploying deformable surgical clips;

FIG. 44 is a cross sectional view showing a fifth embodiment of thedevice for deploying deformable surgical clips;

FIG. 45 is a detail of the hinge point according to one embodiment ofthe deformable surgical clip.

FIG. 46 is a cross sectional view showing a sixth embodiment of thedevice for deploying deformable surgical clips;

FIG. 47 is a perspective view of a deformable surgical clipincorporating fulcrums, shown in a starting position;

FIG. 48 is a perspective view of a deformable surgical clipincorporating fulcrums, shown in a deformed position.

FIG. 49 is a perspective cross sectional view showing an embodiment of amulti legged surgical clip according to the invention.

FIG. 50 is a side view drawing showing an embodiment of a leg and hingeportion of a multi legged surgical clip.

FIGS. 51 a to 51 e are perspective drawings showing several embodimentsof legs for a multi legged surgical clip.

FIG. 52 is a perspective view showing an embodiment of the multi leggedsurgical clip in an open configuration.

FIG. 53 is a perspective view showing the multi legged surgical clip ofFIG. 52 in a closed configuration.

FIG. 54 is a cross sectional view showing an embodiment of the actuationmechanism for the multi legged surgical clip.

FIG. 55 is a cross sectional view of a second embodiment of theactuation mechanism for the multi legged surgical clip.

FIG. 56 is a side view showing a third embodiment of the actuationmechanism for the multi legged surgical clip.

FIG. 57 is a side view showing a fourth embodiment of the actuationmechanism for the multi legged surgical clip.

FIG. 58 is a side view showing a fifth embodiment of the actuationmechanism for the multi legged surgical clip.

FIG. 59 is a cross sectional view showing a sixth embodiment of theactuation mechanism for the multi legged surgical clip.

FIG. 60 is a side view showing an embodiment of an attachment of themulti legged surgical clip.

FIG. 61 is a side view with a detail view of a second embodiment of anattachment of the multi legged surgical clip.

FIG. 62 is a side view with a detail view of a third embodiment of anattachment for the multi legged surgical clip.

FIG. 63 is a side view of a fourth embodiment of an attachment for themulti legged surgical clip.

FIG. 64 is a side view of a fifth embodiment of an attachment for themulti legged surgical clip.

FIG. 65 is a perspective view showing an embodiment of the hinge for themulti legged surgical clip.

FIG. 66 is a side view showing a second embodiment of a hinge for themulti legged surgical clip.

FIG. 67 is a top view showing a third embodiment of a hinge for themulti legged surgical clip.

FIG. 68 is a side view showing an embodiment of the mechanism to controlopening of the multi legged surgical clip.

FIG. 69 is a side view showing a second embodiment of the mechanism tocontrol opening of the multi legged surgical clip.

FIG. 70 is a top view showing a third embodiment of the mechanism tocontrol opening of the multi legged surgical clip.

FIG. 71 is a perspective view showing a fourth embodiment of themechanism to control opening of the multi legged surgical clip.

FIG. 72 is a side view showing a fifth embodiment of the mechanism tocontrol opening of the multi legged surgical clip.

DETAILED DESCRIPTION

FIG. 1 illustrates a first embodiment for a surgical clip that may bedelivered to a site within a patient's body by an endoscopic device. Thesystem and method for delivering surgical clip 10 to the wound site inthe patient's body will be discussed later in this specification.

As can be seen in FIG. 1, surgical clip 10 is comprised of a firstelongated tissue grasping surface 12 which has a first end 12A and asecond end 12B and a second elongated tissue grasping surface 14 alsohaving a first end 14A and a second end 14B. As can also be seen in FIG.1, both the first tissue grasping surface 12 and the second tissuegrasping surface 14 are formed by a semi-circular member.

A first joint 16 and a second joint 18 connect first elongated tissuegrasping surface 12 to second elongated tissue grasping surface 14.First joint 16 is connected at a first end 16A to the first end 12A offirst elongated tissue grasping surface 12 and at a second end 16B tothe first end 14A of second tissue grasping surface 14. Similarly,second joint 18 is connected at a first end 18A to the second end 12B offirst tissue grasping portion 12 and at a second end 18B to the secondend 14B of second tissue grasping surface 14.

In this embodiment for surgical clip 10, the first joint 16 includes asemi-circular portion 16C which is disposed between first end 16A andsecond end 16B. Semi-circular portion 16C extends toward the first andsecond elongated tissue grasping surfaces. Similarly, second joint 18also includes a semi-circular portion 18C between first end 18A andsecond end 18B and which also extends toward the first and secondelongated tissue grasping surfaces. In this embodiment for surgical clip10, both the first and second joints 16, 18, respectively, are formedintegrally with the first and second tissue grasping surfaces 12, 14. Ascan also be seen in FIG. 1, each of the first and second tissue graspingsurfaces includes interlocking teeth 19 which extend from a tissuegrasping surface toward an opposing tissue grasping surface.

First grasping portion 12 and second grasping portion 14 are movablewith respect to each other between a tissue grasping position, as isillustrated in FIG. 1, and a tissue receiving position, as isillustrated in FIG. 2. When the first grasping portion 12 and secondgrasping portion 14 are in the tissue grasping position, body tissue ispositioned between the first grasping portion 12 and the second graspingportion 14 to compress the body tissue between the two graspingsurfaces. Teeth 19 engage the tissue and serve to assist in retainingthe tissue between the two grasping surfaces.

Teeth 19 are not designed to cut through and sever the tissue, butrather, are designed to retain the tissue between the two graspingsurfaces. The first and second joints 16, 18, respectively, bias thefirst tissue grasping surface 12 toward the second tissue graspingsurface 14. Thus, in this embodiment for surgical clip 10, no additionalforce is required to be applied to first tissue grasping surface 12 andsecond tissue grasping surface 14 to compress body tissue between thetwo grasping surfaces. The total compression force required to enablefirst tissue grasping surface 12 and second tissue grasping surface 14to be able to compress and retain tissue between them is solely providedby the biasing force of first joint 16 and second joint 18.

As can be seen in FIG. 2, the first grasping surface 12 and secondgrasping surface 14 are shown in their tissue receiving position. Inorder to position the first and second grasping surfaces in thisorientation, a force F is applied against the grasping surfaces in thedirections as illustrated in FIG. 2. This force is sufficient toovercome the biasing force of first joint 16 and second joint 18 whichbiases the first and second grasping surfaces toward each other in thetissue grasping position. As can be further seen in FIG. 2, when thefirst and second grasping surfaces are in their tissue receivingposition, sufficient area is provided between the two grasping surfacessuch that tissue can be received and grasped between the two graspingsurfaces. When the grasping surfaces are in their tissue receivingposition, it can be seen that first end 16A and second end 16B of firstjoint 16 engage with each other. Similarly, first end 18A and second end18B of second joint 18 also engage with each other. However, it is notrequired that the respective first ends contact the respective secondends. All that is necessary is that sufficient area is provided betweenthe two grasping surfaces such that tissue can be received and graspedbetween the two grasping surfaces. When first joint 16 and second joint18 are in this configuration, the joints store within them an energypotential that, when force F is released from being applied against thefirst and second grasping surfaces, the joints return the first andsecond grasping surfaces to their tissue grasping position.

As will be explained further later in this specification, with surgicalclip 10 in its tissue receiving position, it is placed on the outersurface of an endoscope cap which is included at a distal end of anendoscopic device. By positioning surgical clip 10 on the outer surfaceof the endoscope cap, the endoscope cap provides the force F thatretains surgical clip 10 in its tissue receiving position. As will alsobe further explained later in this specification, once the endoscopicdevice, and thus surgical clip 10, are positioned adjacent to the woundarea within the patient's body, the surgical clip 10 is deployed fromthe endoscope cap to the wound site. When the surgical clip 10 isdeployed off of the endoscope cap, and thus the force F is no longerapplied against the first grasping surface 12 and the second graspingsurface 14, joints 16 and 18 will return the first and second graspingsurfaces to the tissue grasping position which compresses the tissuethat is positioned between the two grasping surfaces. Thus, by deployingthe surgical clip 10 off of the endoscope cap, the body tissue, which ispositioned between the first and second grasping surfaces, will becompressed between the grasping surfaces as a result of the biasingforce applied to the grasping surfaces by the joints which connect thetwo grasping surfaces.

Surgical clip 10 may be comprised of a variety of different types ofmaterials with the only requirement being that the material have theproperties such that it is able to store an energy potential within itwhen the grasping surfaces are moved to their tissue receiving positionand return the grasping surfaces to their tissue grasping position whenthe force that moves the grasping surfaces to their tissue receivingposition is removed. The energy potential stored within the joints isreleased such that the grasping surfaces are biased toward each other totheir tissue grasping position. One such material that could be utilizedfor first and second joints 16, 18, respectively, is a shape-memoryalloy, such as a superelastic Nitinol. This material will provide thejoint with a high mass/force ratio when compared to other biocompatiblematerials because there will be less yield losses during the process ofopening the surgical clip 10 to its tissue receiving position. The useof a shape-memory alloy assumes that the austentite final (A_(f))temperature is below the body temperature of the patient.

Although Nitinol may be a suitable material, there are numerous othermaterials that could also be utilized. Other examples of materials whichcould be utilized for the joints are titanium, stainless steel in aspring steel state, and high yield polymers. Stainless steel in a springsteel state could be utilized if the yield losses could be overcome, orif a multiple component design for the joints is employed, as will bediscussed later in this specification. As mentioned previously, highyield polymers, as well as shape memory polymers and composites may alsobe utilized, especially in multiple component designs.

FIG. 3 illustrates a first embodiment for a system for delivering asurgical clip to a wound site within a patient's body to compress thebody tissue of the wound site. As can be seen, surgical clip 10 isdisposed on an outer surface of endoscope cap 4. Endoscope cap 4 isdisposed on the distal end 1A of an endoscopic device 1. As can befurther seen, and as described previously, when surgical clip 10 isdisposed on the outer surface of endoscope cap 4, first tissue graspingsurface 12 and second tissue grasping surface 14 are in their tissuereceiving position. The present invention is not limited to anyparticular type of endoscopic device or endoscope cap. As will bediscussed later in this specification, the principles of the presentinvention may be utilized in performing any of a variety of differentmedical procedures and the present invention is not limited to any oneparticular type of procedure. The invention has utility in any medicalprocedure where it is desirable to compress body tissue at a wound sitein order to assist in preventing hemorrhaging. Again, endoscope cap 4may be any of a variety of known endoscope caps such as is used invariceal band ligation and snare mucosectomy where the target tissue isdrawn into the space between the faces of the cap and the endoscopicdevice.

As discussed previously, surgical clip 10 is deployed off of endoscopecap 4 after the surgical clip 10 has been positioned adjacent to thewound site. In order to deploy surgical clip 10 from endoscope cap 4, avariety of different types of deployment devices that are associatedwith surgical clip 10 may be utilized. FIG. 4 illustrates a firstembodiment of a deployment device that may be utilized in the presentinvention. As can be seen in FIG. 4, a deployment device, or cable 100,is utilized in deploying surgical clip 10 from endoscope cap 4. As canbe seen, a distal end 110 of cable 100 is looped around a portion ofsurgical clip 10. Cable 100 is then positioned through a working channelof the endoscopic device 1 where a proximal end 120 of cable 100 extendsfrom a proximal end of the endoscopic device 1 which extends out of thepatient's body. Thus, as can be understood, when the person who isperforming the procedure pulls on the proximal end 120 of cable 100,which pulls cable 100 from a distal end to a proximal end of endoscopicdevice 1, surgical clip 10 will be pulled towards the distal end ofendoscope cap 4 and thus off of endoscope cap 4 to deploy surgical clip10 from the endoscope cap. This methodology is similar to variceal bandligation methods.

FIG. 5 illustrates a second embodiment for a deployment device that maybe utilized in the present invention. As can be seen in FIG. 5, thesecond embodiment for the deployment device is a tubular member 200 thatis disposed around the endoscopic device 1. Tubular member 200 ismovable on endoscopic device 1 between a position where distal end 210of tubular member 200 does not engage with surgical clip 10 and aposition where distal end 210 engages with surgical clip 10. By applyinga force at proximal end 220 of tubular member 200, distal end 210 can bemoved such that it engages with surgical clip 10. Further movement oftubular member 200 in a distal direction will deploy surgical clip 10from endoscope cap 4. As can be understood, proximal end 220 of tubularmember 200 extends outside of the patient such that a force may beapplied to proximal end 220 to move tubular member 200 such that distalend 210 engages with surgical clip 10 to deploy surgical clip 10 fromendoscope cap 4.

FIG. 6 illustrates a third embodiment for a deployment device. In theembodiment of FIG. 6, the deployment device comprises a balloon 300where at least a portion of balloon 300 is disposed between surgicalclip 10 and endoscope cap 4. An inflation lumen 310 extends from balloon300 to a position outside of the patient such that pressure may beapplied to balloon 300 to inflate balloon 300. Any substance may beutilized to inflate the balloon, including a gas, liquid, or any othersubstance. As can be understood, balloon 300 may be maintained in astate of inflation such that balloon 300 does not force surgical clip 10off of endoscope cap 4. When the surgeon desires to deploy surgical clip10 from endoscope cap 4, the surgeon would inflate balloon 300 to astate such that the inflation of balloon 300 causes surgical clip 10 tobe moved toward the distal end of endoscope cap 4 such that continuedinflation of balloon 300 will deploy surgical clip 10 off of endoscopecap 4.

As the balloon inflates, the force applied to surgical clip 10 servestwo functions. First, as the balloon expands, surgical clip 10 alsoexpands which helps to overcome the clamping force of the first andsecond grasping surfaces 12, 14, respectively, against the endoscope cap4. As the surgical clip 10 radial force is reduced by the expandingballoon 300, the expanding balloon pushes, as described previously,surgical clip 10 off of endoscope cap 4 and onto the target tissue. Anadvantage of this methodology for deploying surgical clip 10 off ofendoscope cap 4 is that there is no external force applied against theendoscope cap 4/endoscopic device 1/surgical clip 10 assembly such as isapplied by the previously discussed embodiments for a deployment device,i.e., cable 100 or tubular member 200. Thus, deployment of surgical clip10 from endoscope cap 4 by balloon 300 will help to reduce a possibilitythat the surgical instrument 1000 could be pushed away from the targetwound site as a result of deploying surgical clip 10 from endoscope cap4.

Similar in concept to the balloon deployment mechanism discussedpreviously, a force generator that is disposed around the endoscopicdevice 1 may be utilized to deploy surgical clip 10 from endoscope cap4. The force generator may include various mechanisms for deployingsurgical clip 10 from endoscope cap 4 and several of these alternativeswill be discussed below.

FIG. 7 illustrates a fourth embodiment of a deployment device 400 thatincorporates a force generator 410 that is disposed around endoscopicdevice 1 and is located proximal to surgical clip 10. As can be seen inFIGS. 7 and 8, force generator 410 includes an engagement member 420that is at least partially disposed within the force generator 410 andwhich is movable between a first position where a distal end 422 ofengagement member 420 does not engage with surgical clip 10 and a secondposition where distal end 422 of engagement member 420 engages withsurgical clip 10. An actuator 440 is contained within force generator410 for moving engagement member 420 to its second position where itengages with surgical clip 10.

FIG. 8 is a cross sectional view that further illustrates the fourthembodiment for deployment device 400 that includes force generator 410.As can be seen in FIG. 8, engagement member 420 is at least partiallydisposed within force generator 410. A retention spring 425 may beutilized to bias engagement member 420 in its first position where itdoes not engage with surgical clip 10. Retention spring 425 ispositioned within force generator 410 such that it is disposed between adistal wall 410A of force generator 410 and piston 426 of engagementmember 420. Thus, the tension spring 425 applies a force F_(4/2) againstpiston 426 that biases engagement member 420 in its first position.Retention spring 425 is disposed around shaft 424 of engagement member420. Actuator 440, in this embodiment, is a compression spring that isdisposed within force generator 410 and between piston 426 and aproximal wall 410B of force generator 410. A cable 430, which extendsfrom a position outside of the patient's body at a proximal end to aposition within force generator 410 at a distal location, is attached tocompression spring 440 to retain compression spring 440 in a compressedconfiguration. When cable 430 is released from compression spring 440,compression spring 440 applies a force F_(4/1) against piston 426 ofengagement member 420. The magnitude of force F_(4/1) is greater thanthe force applied by retention spring 425, i.e., F_(4/2). Thus, whencable 430 is released from compression spring 440, compression spring440 acts upon piston 426 which in-turn extends distal end 422 ofengagement member 420 such that it engages with surgical clip 10. Asengagement member 420 continues its further extension from forcegenerator 410 under the action of compression spring 440, engagementmember 420 forces surgical clip 10 off of endoscope cap 4. As can beseen in FIG. 8, distal end 422 of engagement member 420 is formed in atapered configuration such that distal end 422 is assisted in engagingwith surgical clip 10 and forcing surgical clip 10 off of endoscope cap4. The tapered surface of distal end 422 of engagement member 420applies both a radial and linear force to the surgical clip.

FIGS. 9 and 10 illustrate alternative embodiments for the forcegenerator Whereas these alternative embodiments for the force generatordo not illustrate a retention spring, it is to be understood that aretention spring as described above can be utilized in any of theadditional embodiments contemplated for a force generator in order toprovide a biasing force to assist in retaining the engagement member inits first position where it does not force surgical clip 10 off ofendoscope cap 4. Additionally, whereas it has been described that theengagement member does not engage with the surgical clip when it is inits first position, it is not required that the engagement member doesnot engage with the surgical clip. All that is required is that theengagement member does not apply a force to the surgical clip that wouldtend to force the surgical clip off of the endoscope cap before it isdesired to do so.

As stated above, FIGS. 9 and 10 illustrate alternative embodiments for aforce generator which operate similar to the force generator previouslydiscussed. The significant difference between the embodiments is thephysical structure and operation of the actuator that is utilized tomove the engagement member to its second position where it engages thesurgical clip and deploys the surgical clip off of the endoscope cap.FIG. 9, therefore, illustrates a fifth embodiment for a deploymentdevice 500 that includes a force generator 510. Again, as discussedpreviously, force generator 510 operates similarly to force generator410. As such, force generator 510 includes an engagement member 520 thatincludes a shaft 524, a piston 526, and a distal end 522 that engageswith the surgical clip 10. However, force generator 510 utilizes anactuator for moving engagement member 520 that comprises a pressurizablechamber 540 that is disposed between piston 526 and proximal wall 510Bof force generator 510. A pressure supply line 530 extends from aproximal end where it is located outside of the patient's body to adistal end where it is in communication with chamber 540. As chamber 540is pressurized, a force F₅ is applied against piston 526 which movesengagement member 520 such that it will engage with the surgical clipand deploy the surgical clip off of the endoscope cap. In order toprovide for a sealed chamber 540, a first seal 525A may be disposedbetween piston 526 and inside wall 500A of force generator 510 and asecond seal 525B may be disposed between piston 526 and outside wall500B of force generator 510. Thus, a sealed chamber 540 may be providedsuch that as the chamber is pressurized, piston 526 is moved withinforce generator 510.

Force generator 510 may utilize any of a variety of means forpressurizing the chamber, such as a gas or a liquid, and the presentinvention is not limited to any particular substance for pressurizingchamber 540. For example, the pressure can be supplied by injecting airinto chamber 540 with a syringe. In an alternative embodiment, ratherthan utilizing pressure within chamber 540, a vacuum could be utilizedto maintain the engagement member in a retracted position prior todeployment of the surgical clip.

FIG. 10 illustrates a sixth embodiment for deployment device 600 thatutilizes a force generator 610 that incorporates an electrical coil 640as the actuator for moving engagement member 620. As discussedpreviously, force generator 610 includes an engagement member 620 thathas a shaft 624, a piston 626, and a distal end 622 that engages withthe surgical clip. As can be seen, an electrical coil 640 is providedwithin force generator 610 at a location within force generator 610 thatis proximal to piston 626. An electrically conductive cable 630 extendsfrom electrical coil 640 proximally to a position where it exits thepatient's body. Cable 630 provides a transmission means for energizingelectrical coil 640. When electrical coil 640 is energized, it providesa force F₆ against piston 626 to move engagement member 620 such thatits distal end 622 will engage with the surgical clip to deploy thesurgical clip off of the endoscope cap. Thus, a current may be providedthrough cable 630 to electrical coil 640 to create an opposing chargeagainst engagement member 620. As such, engagement member 620 could be acharged magnet or could be constructed of a ferrous metal.

The present invention is not limited to any particular structure for theforce generator embodiments described above, in that, the forcegenerators may be formed integrally with the endoscope cap or may beformed separate from the endoscope cap and disposed around the endoscopecap such that its engagement member is able to engage with the surgicalclip. It may be advantageous to integrate the force generator, and thusthe deployment force required, within the endoscope cap, however, thepresent invention is not limited to integrating the force generatorwithin the cap.

As can be seen in FIGS. 11 through 13, the system for deploying asurgical clip within the patient's body may also include a tissuegrasping device that may be disposed through a working channel of theendoscopic device. The present invention is not limited to anyparticular embodiment for a tissue grasping device and FIGS. 11 through13 illustrate alternative embodiments for the tissue grasping device.The purpose of the tissue grasping device is to manipulate the targettissue that is to be compressed such that it is positioned within theendoscope cap. The tissue grasping device may be utilized in conjunctionwith suction that is applied to the tissue through the working channelof the endoscopic device. The suction would assist in positioning thetarget tissue within the endoscope cap. However, it is not required thatone or the other of a tissue grasping device or a vacuum be utilized. Inthe present invention, either a tissue grasping device or suction, or acombination of the two, can be utilized with the present invention. Allthat is desired is that a mechanism be provided to assist in positioningthe target tissue within the endoscope cap.

One advantage that would be possible if a grasping device that is passedthrough the working channel of the endoscopic device is used would bethat this grasping device could also be used as a guide to push theendoscopic device to the wound site. Another advantage to utilizing agrasping device is that it could help to maintain the endoscopicdevice's position relative to the wound site during the surgical clip'sdeployment from the endoscope cap.

FIG. 11 illustrates a first embodiment for a tissue grasping device thatcould be utilized in the present invention. In FIG. 11, tissue graspingdevice 6 is illustrated as being disposed through a working channel (notvisible) of the endoscopic device 1. It is noted that the endoscope capand the surgical clip is not illustrated in FIGS. 11 through 13,however, based upon the previously provided discussion, it can beunderstood how these components would be configured on endoscopic device1. Tissue grasping device 6 is illustrated as a solid tapered threadedmember. With tissue grasping device 6, grasping of the targeted tissuewould be accomplished by screwing the distal end of tissue graspingdevice 6 into the tissue. The screwing action could be accomplishedeither by rotating the entire sheath of the endoscopic device 1 or byrotating the tissue grasping device 6 within the sheath, e.g., analogousto a flexible drive shaft. When the device 6 is within the tissue, thetissue can be pulled within the endoscope cap. After deployment of thesurgical clip, the tissue grasping device 6 would be unscrewed prior toremoval of the endoscopic device 1.

FIG. 12 illustrates an alternative embodiment for a screw-shaped tissuegrasping device 8. Tissue grasping device 8 functions similarly to thetissue grasping device 6 discussed in connection with FIG. 11, however,the design of tissue grasping device 8 is configured as a taperedspring-type of device as opposed to the solid tapered design of FIG. 11.However, tissue grasping device 8 is utilized in the same manner as wasdescribed for tissue grasping device 6.

FIG. 13 illustrates the sequential steps involved in utilizing a thirdembodiment for a tissue grasping device 9 as it is deployed into theorgan wall of the targeted tissue. In the embodiment of FIG. 13, tissuegrasping device 9 includes at least one J-shaped barb. In FIG. 13, afirst barb 9A and a second barb 9B are illustrated. When the barbs aredisposed within endoscopic device 1, the barbs are not formed in aJ-shape but rather are forcibly configured in an elongated shape. Thus,the barbs are spring-formed into their J-shape and when the barbs areretracted into the endoscopic device 1, the barbs are elongated againstthe biasing force that wants to form them in their J-shape throughinteraction of the walls of endoscopic device 1 against the barbs.

When the endoscopic device 1 is placed against the targeted tissue, thesharp barbs are extended out of the endoscopic device 1, or out of acatheter included within endoscopic device 1 which contains the barbs,and into the tissue. When the barbs are extended from endoscopic device1, the barbs pierce the organ wall and, since endoscopic device 1 is nolonger restraining the ends of the barbs, as the barbs exit theendoscopic device and enter the targeted tissue the barbs reform theirJ-shape within the tissue and thus are able to engage with the tissueand retain the tissue on the J-shaped member. The barbs are formed witha sufficient amount of spring force to retain the J-shape in the barbssuch that the barbs are able to lift and position the tissue within theendoscope cap. Again, after deployment of the surgical clip, the barbsmay be retracted within the endoscopic device before the endoscopicdevice is removed from the patient's body. The present invention is notlimited to any particular number of J-shaped barbs and any number ofbarbs can be utilized with the present invention.

As discussed previously, the present invention is not limited to anyparticular embodiment for a tissue grasping device and any of a varietyof known grasper/forceps devices that are well-known in the art could beutilized with the present invention.

As can be seen in FIG. 3, surgical clip 10 extends radially fromendoscope cap 4 such that it could possibly be desired to include in thepresent invention structures that could assist in intubating the systemwithin the patient's body. As the endoscopic device, which is loadedwith the surgical clip, is passed through, for example, the oral cavity,trachea and esophagus of the patient, it is desired that the surgicalclip should not cause any injury to the patient. Several alternativeembodiments for assisting in intubation are provided.

Referring back to FIG. 6, balloon 300 may also be utilized to assist inintubation as well as for use in deploying surgical clip 10. Forassisting in intubation, balloon 300, which is located proximal tosurgical clip 10, could be inflated to a diameter which exceeds theradially extending diameter of surgical clip 10. Thus, the balloon 300would ride against the lumen wall which would keep the surgical clip 10out of contact with the lumen wall. The balloon 300 could be partiallyinflated so as not to deploy surgical clip 10 but yet provide forassisting in intubation of surgical clip 10 within the patient's body.As such, when the balloon 300 is partially inflated, the balloon has adiameter at a portion 305 of the balloon which is located proximal tosurgical clip 10 which is greater than a diameter of the surgical clip.

An alternative embodiment for a device to assist in intubation whichwould function similar to the balloon discussed previously isillustrated in FIG. 14. FIG. 14 illustrates a second embodiment for anintubation mechanism 700. Intubation mechanism 700 is comprised of afoam member that is disposed on the endoscope cap 4. Alternatively, foammember 700 could be formed integral with endoscope cap 4. The foammember 700 has a diameter at a portion 705 of foam member 700 which islocated proximal to surgical clip 10 which is greater than the diameterof surgical clip 10. Thus, as the surgical clip is inserted into thebody of the patient, the greater diameter of foam member 700 wouldprevent the surgical clip from harming the lumen through which thesurgical clip is inserted.

FIG. 15 illustrates a third embodiment for an intubation mechanism 800that could be utilized with the present invention. Intubation mechanism800 is comprised of a retractable cover 802 which is attached to atubular member 804. Cover 802 is movable by moving tube 804 between afirst position where cover 802 covers surgical clip 10 and a secondposition where cover 802 is not disposed over surgical clip 10. Bycovering surgical clip 10 with cover 802, the walls of the lumen areprotected from potential injury from surgical clip 10. The cover 802,which is attached to a tubular member which could be similar to thatdescribed in FIG. 5, could be slid back from covering surgical clip 10after intubation, when the targeted lesion is visualized.

Alternatively, cover 802 could be integrated into the second embodimentfor the deployment device as illustrated in FIG. 5 which comprisedtubular member 200. In this embodiment where a cover was integrated intoa tubular deployment device, the cover would not be retracted untilafter the surgical clip is deployed by the tubular member.

FIG. 16 illustrates a fourth embodiment for an intubation mechanism 900.As illustrated in FIG. 16, an intubation overtube 900, which iswell-known in the art and which would extend from, for example, the oralcavity into the gastric or duodenal bulb could also be utilized toprotect the lumen walls. The overtube could be placed prior tointubation over the surgical clip-loaded endoscopic device. An advantageto this embodiment for an intubation mechanism is the relatively easymultiple intubations possible if multiple clips are required. Anotheradvantage is that the overtube could include working lumens that couldbe utilized to irrigate, aspirate, and provide access for secondarydevices. A third advantage could be that the overtube could provideadditional support for the endoscopic device during deployment, whichcould assist in overcoming a force opposing movement of the endoscopicdevice.

Further description will now be provided of an embodiment for theprocedure for deploying the surgical clip in accordance with theprinciples of the present invention. First, the target ulcer or lesionis diagnosed visually with the endoscopic device by the clinician. Afterdiagnosis, the endoscopic device is withdrawn and the endoscope cap,which is loaded with the surgical clip, is attached to the endoscopicdevice. It is noted that other factors may make the clinician decidebefore the diagnostic intubation that bleeding is occurring which wouldpossibly prompt the clinician to load the surgical clip onto theendoscopic device prior to diagnostic intubation.

The endoscope is manipulated such that it is positioned near the woundsite. If there is active bleeding, the clinician may irrigate the woundusing the working channel of the endoscope to improve visualization. Ifthere is active bleeding, or if a rupture could be imminent, theclinician may decide to inject a sclerosing/vasoconstricting drug byneedle therapy through the working channel of the endoscope. The goal ofsuch being to maintain a temporary, clear field of view during theprocess of applying the surgical clip. The drug delivery device couldalso be used to clear the field with irrigation. It is also possiblethat the clinician may decide to pretreat the wound site with a thermaldevice (including irrigation) for the same reasons. Additionally, it isalso possible that the clinician may decide to utilize injection and/orthermal therapy as a combination treatment with the surgical clip.

When the decision to apply the surgical clip is made, the target tissue,as discussed previously, first needs to be manipulated within theendoscope cap. The working channel of the endoscope can now be utilizedfor tissue manipulation. The endoscope cap can be manipulated proximalto, and against the wound site, before suction is applied through theworking channel to aspirate the tissue into the endoscope cap andmaintain scope position during the deployment of the surgical clip. Asalso discussed previously, a tissue grasping device can be passedthrough the working channel of the endoscope to grasp and pull thetissue into the endoscope cap. After grasping the tissue, the tissuegrasping device can also be used as a guide to push the endoscope to thewound site. As also discussed previously, another advantage to thisgrasping technique is that it will help to maintain the scope's positionduring the deployment of the surgical clip. Again, grasping andaspiration may also be used in combination.

When the target tissue is within the endoscope cap, the surgical clip isdeployed off of the end of the endoscope cap, thus compressing thetissue surrounding the wound to create the desired mechanicalcompression.

The surgical clip, in this procedure, is not intended to be a permanentimplant. It is intended to remain in-place until permanent healing isattained, which may be a period of between 48 hours to two weeks. Thesurgical clip is intended to slough off over time due to the tissue thatis compressed within the surgical clip dying from the loss of bloodsupply to the tissue and/or a slow cutting action applied by thesurgical clip itself to the tissue. After sloughing off, the surgicalclip is passed as part of the patient's normal digestion. The surgicalclip's depth of penetration should be well into the submucosa, but notthrough the muscularis to perforate into the peritoneum.

The surgical clip is primarily intended to be successfully deployed andeffect hemostasis in a single application. However, a failed deployment,poor location, or a large lesion could require application of multiplesurgical clips. Should multiple clips be required, additional clipscould be reloaded onto the endoscope cap during the procedure. Forexample, a surgical clip could be deployed and then the endoscopicdevice could be removed from the patient's body. A second surgical clipcould then be loaded onto the endoscopic device. The reloaded endoscopicdevice could then be reinserted into the patient's body for deploymentof the second surgical clip. It is also contemplated that the presentinvention could incorporate multiple surgical clips that are preloadedfor deployment on the endoscopic device and deployed in a singleintubation procedure. These multiple preloaded clips could be deployedin a manner similar to that as utilized in multiple firing band ligationdevices.

An alternative procedure is contemplated for deploying the surgicalclip. As described previously, the surgical clip has been described asbeing comprised of a shape-memory alloy that is deployed within the bodyin an austentite final phase, i.e., where the material of the joints areformed such that they fully store energy such that the first and secondgrasping surfaces are returned to their tissue grasping position whenthe surgical clip is deployed from the endoscope cap. However, theshape-memory alloy could also be used effectively for comprising thesurgical clip by deploying the surgical clip in some level of themartensite phase, or “soft” phase, where the joints are formed such thatthey do not fully store an energy potential within them in this phasefor the shape-memory material. By loading the surgical clip in amartensite phase, it could assist in deploying the surgical clip byreducing the force as applied on the endoscope cap by the surgical clipprior to deployment of the surgical clip. As can be understood, when thesurgical clip is deployed on the endoscope cap, the first and secondgrasping surfaces of the surgical clip, because they are normally biasedtoward each other, apply a force on the endoscope cap. Thus, this forceapplied by the surgical clip on the endoscope cap could bedisadvantageous when applying the force to deploy the surgical clip fromthe endoscope cap. Therefore, if the surgical clip is positioned on theendoscope cap in a martensite phase, the force applied to the endoscopecap by the surgical clip would not be as great and thus, deployment ofthe surgical clip off of the endoscope cap could be accomplished moreeasily. However, if this change in material phase for the surgical clipis utilized in the present invention, an alternative procedure fordeploying the surgical clip would be utilized.

The alternative procedure for deploying the surgical clip off of theendoscope cap where the surgical clip was positioned on the cap in amartensite phase encompasses loading the surgical clip onto the cap inits “soft” phase. The tissue is then manipulated into the endoscope cap,as described previously. The surgical clip is then deployed by any ofthe deployment mechanisms described previously where, after deploymentof the surgical clip, the surgical clip softly compresses the targetedtissue. The endoscopic device is slightly retracted from the wound siteand the surgical clip is then heated to a temperature that is above theaustentite final (A_(f)) temperature by, for example, applying hot waterthrough the endoscope or by applying a heating current to the surgicalclip with a secondary heating device that could be deployed through theendoscope, e.g., snares, hot forceps, etc. Preferably, the martensitestart (M_(s)) temperature will be below body temperature.Advantageously, electrical heating can provide a secondary benefit inthe procedure by cauterizing the tissue.

Whereas a first embodiment for surgical clip 10 has been discussed, thepresent invention is not limited to any particular embodiment or sizefor the surgical clip. The size of the surgical clip may vary for use indifferent procedures and on different endoscopic devices. FIGS. 17through 33, which will be discussed below, illustrate alternativeembodiments for a surgical clip in accordance with the presentinvention.

FIG. 17 illustrates a second embodiment for a surgical clip 20 inaccordance with the principles of the present invention. As can be seenin FIG. 17, as opposed to the first embodiment of surgical clip 10illustrated in FIG. 1, surgical clip 20 includes a greater number ofteeth 21. Thus, the present invention is not limited to any particularnumber of teeth that are included on the first and second graspingsurfaces. Additionally, the size and form of the teeth may vary. Forexample, a single, flat, tooth may be provided on each grasping surfaceas opposed to a plurality of teeth on each grasping surface. Providing asingle, flat, tooth may be preferred if a high clamping force isprovided to the surgical clip. Alternatively, instead of teeth, theinterface between the two grasping surfaces may be formed more as wavesor shallow teeth with a large pitch. Again, the present invention is notlimited to any particular number or configuration of teeth. The onlyconsideration is that the interface between the first and secondgrasping surfaces provide a holding force that prevents the surgicalclip from migrating off of the tissue that is to be compressed but yetnot be so invasive as to tear through the tissue prematurely.

FIG. 18 illustrates a third embodiment for surgical clip 25. As can beseen, surgical clip 25 includes first and second grasping portions 26,27, respectively, which are formed as straight members which is incontrast to the embodiment of FIG. 1 where the first and second graspingportions were formed as semi-circular members. Thus, the graspingportions may be formed in a variety of configurations which may havewider or narrower widths. A benefit of including wide grasping portionsin a flat configuration as illustrated in FIG. 18 is for use in treatinglarger wound sites.

Whereas the embodiments discussed previously for the surgical clipillustrate grasping portions that define a slight gap between them whenthey are in their tissue grasping position, which may be preferred toallow for space to receive the tissue, alternatively, the opposinggrasping portions could be normally closed, i.e., engaging with eachother, with the clamping force lessened in order to compress tissuebetween the grasping surfaces without cutting through the tissueprematurely.

Various alternative designs for the joints which interconnect the twograsping surfaces are also contemplated. These alternative joint designscan provide for application of different forces which may be preferable,provide for use of the surgical clip in other surgical procedures, or toallow for use of different materials in forming the joints. FIGS. 19 and20 illustrate an alternative joint design where the joint is enlarged incomparison to the joint illustrated in the first embodiment of surgicalclip 10 illustrated in FIG. 1. Additionally, the semi-circular portionof the joints of FIGS. 19 and 20 extend outwardly or away from thegrasping surfaces.

As can be seen in FIG. 19, first joint 31 and second joint 32 ofsurgical clip 30 are larger in size than that previously described.Similarly, as illustrated in FIG. 20, first joint 36 and second joint 37of a fifth embodiment for surgical clip 35 are also enlarged whencompared to the first embodiment of surgical clip 10. By enlarging thejoint, the joint spreads the opening yield force over more jointmaterial. This may be advantageous where lower yield materials areutilized to comprise the joints.

FIG. 21 illustrates a sixth embodiment of a surgical clip 40 thatincludes an alternative joint design. As can be seen in FIG. 21, secondjoint 42 includes additional material to the joint centerpoint 42A.First joint 41 is similarly formed. The provision of additional materialto the joints' centerpoint could increase the clamping force that isable to be provided by the joints.

FIG. 22 illustrates a seventh embodiment of a surgical clip 45 thatincludes a torsion design for first joint 46 and second joint 47. Thetorsion design of the joints comprises a figure-eight configuration.Designing the joints in this configuration could be advantageous in thatthey could provide a high force potential when utilizing lower yieldmaterials for the joints.

FIGS. 23 through 31 illustrate alternative embodiments for the jointswhich utilize multiple and/or different components for the joints. Ascan be seen in FIG. 23, an eighth embodiment for surgical clip 50 isillustrated that utilizes compression springs for first joint 51 andsecond joint 52. The compression springs connect to the ends of thegrasping surfaces and provide the biasing force to bias the graspingsurfaces toward each other in their tissue grasping position.

FIGS. 24 through 26 illustrate alternative embodiments for the jointswhere springs are used as an additional component in comprising a jointassembly. As can be seen in FIG. 24, a ninth embodiment for a surgicalclip 55 includes a first extension spring 56A and a second extensionspring 57A that are a component of the joint assemblies. Thus, theextension springs 56A, 57A may be utilized to assist the joints 56 and57, respectively, in applying the biasing force to the first and secondgrasping surfaces. As is also illustrated in FIG. 24, hinge point 56B ofjoint 56 may be notched as shown so that the majority of the force thatis applied is controlled by the springs. Similarly, second joint 57 isnotched at its hinge point 57B. Alternatively, the hinge points may beformed as pinned pivot points so that the springs provide the entireclosing force on the tissue grasping surfaces.

FIG. 25 illustrates a tenth embodiment for a surgical clip 60 thatincludes torsion springs 61A and 62A as components of first joint 61 andsecond joint 62, respectively. Similar to the springs of FIG. 24,torsion spring 61A and 62A maybe utilized to assist in providing aclosing force to the tissue grasping surfaces. The force applied by thetorsion springs is a force in addition to the force applied by the basematerial of the first and second joints. Alternatively, the joints mayalso include a pinned pivot joint as described above so that the torsionsprings provide the entire closing force.

Similarly, FIG. 26 illustrates an eleventh embodiment for a surgicalclip 65 that has a first joint 66 that includes a torsion spring 66A anda second joint 67 that includes a second torsion spring 67A. The torsionsprings 66A and 67A function as described in the previous embodiments.

FIGS. 27 through 31 illustrate alternative embodiments for the surgicalclip which include elastomeric bands as components of the joints. As canbe seen in FIG. 27, a twelfth embodiment for a surgical clip 70 isillustrated that has a first joint 71 and a second joint 72. Elastomericband 71A is included as a component of first joint 71 and elastomericband 72A is included as a component of second joint 72. As can be seenin FIG. 27, the elastomeric bands 71A and 72A are formed such that theyare able to stretch, and thus elongate, when the tissue graspingportions are moved to their tissue receiving position and thus assisttheir respective joints in applying the biasing force to the graspingportions to return them to their tissue grasping position. In thisembodiment for surgical clip 70, the elastomeric bands 71A and 72A areattached at first joint 71 and second joint 72, respectively, such as byutilizing an attachment mechanism, e.g., a pin or a screw. Theelastomeric bands are attached at an outer surface of their respectivejoints. As can be further seen in FIG. 27, first joint 71 includes anotch 71B at its pivot point and second joint 72 includes a notch 72B atits pivot point.

FIG. 28 illustrates a thirteenth embodiment for a surgical clip 75 thatincludes elastomeric bands 76A and 77A as parts of first joint 76 andsecond joint 77, respectively. In contrast to the embodiment of FIG. 27,the embodiment of FIG. 28 includes oval-shaped elastomeric bands thatare positioned on and around their respective joints rather than beingattached to an outside surface of the joints. Additionally, in theembodiment of FIG. 28, first joint 76 includes a pinned pivot point 76Band second joint 77 includes a pinned pivot point 77B such that theentire biasing force which biases the first grasping surface toward thesecond grasping surface is provided solely by the elastomeric bands.

FIG. 29 illustrates a fourteenth embodiment for a surgical clip 80 thatalso includes an elastomeric band 81A as a component of first joint 81and an elastomeric band 82A as a component of second joint 82. Theelastomeric bands of FIG. 29 are positioned on their respective jointssimilar to the manner that the elastomeric bands were positioned in theembodiment of FIG. 28 in that they are oval-shaped members and aredisposed around, and on, their respective joints. However, in theembodiment of FIG. 29 as opposed to the embodiment of FIG. 28, firstjoint 81 includes a notched pivot point 81B and second joint 82 includesa notched pivot point 82B such that the elastomeric bands assist inproviding the biasing force to the first and second grasping surfacesand thus do not apply the full biasing force. The base material of thefirst and second joints also provide a biasing force to the first andsecond grasping surfaces.

FIG. 30 illustrates a fifteenth embodiment for a surgical clip 85 inaccordance with the principles of the present invention. Surgical clip85 also has a first joint 86 and a second joint 87 and includes a singleelastomeric band 88 which is disposed over and around both joints 86 and87. Thus, in contrast to the previously disclosed embodiments where twoelastomeric bands were utilized, one for each joint of the surgicalclip, the embodiment of FIG. 30 utilizes a single elastomeric band 88that can either assist in providing a biasing force to the first andsecond grasping portions or can provide the entire biasing force to thefirst and second grasping surfaces.

FIG. 31 illustrates a sixteenth embodiment for a surgical clip 90.Again, surgical clip 90 has a first joint 91 and a second joint 92 andincluded in each joint is an elastomeric band 91A and 92A, respectively.Elastomeric bands 91A and 92A may either assist in providing the biasingforce to the first and second grasping surfaces or may provide theentire biasing force to the grasping surfaces. However, in contrast tothe embodiments of FIGS. 28 and 29, the embodiment of FIG. 31 includesan elongated elastomeric band that is disposed on the entirety of itsrespective joint. Thus, the elastomeric band is formed in a generallytriangularly-shaped configuration to conform to the shape of the jointon which it is disposed.

As discussed previously, when the surgical clip is disposed on theendoscope cap in its tissue receiving position, the tissue graspingsurfaces of the surgical clip may exert a force on the endoscope capwhich may disadvantageously effect the deployment of the surgical clipoff of the endoscope cap. Therefore, it may be desirable to provide alocking mechanism on the surgical clip that could assist in maintainingthe surgical clip in its tissue receiving position and which could alsoserve to reduce the force applied by the surgical clip on the endoscopecap. However, once the surgical clip is deployed off of the endoscopecap, the lock would disengage under the biasing pressure applied by theconnecting joints such that the tissue grasping surfaces of the surgicalclip could return to their tissue grasping position. FIGS. 32 and 33illustrate two possible alternatives for providing such a lockingmechanism.

FIG. 32 illustrates a seventeenth embodiment for a surgical clip 94 thatincludes a first embodiment for a lock mechanism Lock mechanism 95includes a plurality of notches 95A at a first end of surgical clip 94on a first side of surgical clip 94 and a pawl 95B on a second end ofsurgical clip 94 on the first side of surgical clip 94. When surgicalclip 94 is positioned in its tissue receiving position, pawl 95B isreceived within one of the plurality of notches 95A to assist in lockingsurgical clip 94 in its tissue receiving position until it is deployedoff of the endoscope cap. As discussed previously, when the surgicalclip 94 is deployed off of the endoscope cap, the biasing force appliedby joint 96 to return the grasping surfaces to their tissue graspingposition is sufficient to overcome the engagement force between pawl 95Band notches 95A such that pawl 95B will become disengaged from one ofthe notches 95A such that surgical clip 94 may return to its tissuegrasping position. As can be seen in FIG. 32, a second side of surgicalclip 94 also includes a pawl and notch locking mechanism.

As can be seen in FIG. 33, an eighteenth embodiment for a surgical clip97 is illustrated which includes a second embodiment for a lock 98. Lock98 operates similarly to the lock as described in FIG. 32, however, theinterlocking mechanism now utilizes a ball joint 98B that is receivedwithin a slot 98A that is defined on a side in an end of surgical clip97. Again, lock 98 serves to assist in retaining surgical clip 97 in itstissue receiving position and becomes disengaged after surgical clip 97is deployed from the endoscope cap and joint 99 biases the graspingsurfaces toward each other to their tissue grasping position. Again, asecond side of surgical clip 97 may also include a lock 98.

Other alternative designs are contemplated for assisting in deployingthe surgical clip off of the endoscope cap. For example, the endoscopecap could include a surface that is conducive to minimizing thefrictional forces between the surgical clip and the endoscope cap. Thissurface could be comprised of hard, smooth surfaces which could includeany of a variety of surface treatments to minimize the frictional forcesbetween the surgical clip and the endoscope cap.

Alternatively, it is contemplated that another mechanism that could beutilized to reduce the clamping force as applied by the surgical clip onthe endoscope cap is a cam-type hinge. The cam-type hinge would reducethe closing force applied by the surgical clip on the endoscope cap whenthe surgical clip is in its tissue receiving position. Upon deploymentof the surgical clip, the fall closing force of the surgical clip wouldbe employed. This cam-type hinge is similar in design and concept to athat used in a compound archery bow.

In a different embodiment, the invention includes a surgical clip thathas an open position in which the tissue grasping surfaces are apart,and a closed position where the tissue grasping surfaces are broughttogether. The deformable surgical clip moves from the open to the closedposition as a result of a force applied externally, for example by thedeployment mechanism described below. In the open position, thedeformable surgical clip can be inserted in the patient's body andpositioned where desired. The deformable clip is then moved to theclosed position while tissue is placed between the grasping surfaces, sothe tissue is compressed by the clip.

FIG. 34 shows an exploded view of one embodiment of an exemplary deviceused to deploy a deformable surgical clip. Deformable clip 110 isinitially loaded in a deployment device 120 that includes a piston foot112, an endoscope 114, a body 116, fulcrum portions 118 and a slidingsleeve 122. In addition, deployment device 120 can also include anendoscope stop 124 and a piston spacer 126.

The deformable surgical clip 110 is shown in greater detail in FIGS. 35and 36. Clip 110 in FIG. 35 is shown in the initial, non deformedconfiguration, that exists when the clip 110 is loaded in deploymentdevice 120. In use, clip 110 is placed on the tissue and a force isapplied to push points 128, in a direction perpendicular to the plane ofthe undeformed clip, towards the tissue. At the same time, an oppositeforce is applied to the clip at hinge points 130. The combination offorces causes the clip 110 to bend at hinge points 130, and fold to theconfiguration shown in FIG. 36. In this configuration, tissue graspingedges 132 close on and clamp the selected tissue.

As shown in FIG. 37, the clip 110 is mounted at the tip of body 116 ofthe deployment device 120. In one exemplary embodiment, body 116 of thedeployment device 120 can be fitted on the tip of an endoscope, toenable the operator to see where clip 110 is placed. Clip 110 isretained in position within body 116 by the fulcrum portions 118.Fulcrum portions 118 contact clip 110 at hinge points 130. When pistonfoot 112 applies a force in direction F to push points 128, shown by thearrow, fulcrum portions 118 prevent clip 110 from moving, and apply anopposite force to the clip 110. Clip 110 then folds over at hinge points130 due to the action of fulcrum portions 118. As can be seen in FIG.37, piston foot 112 contains an obround slot or hollow section in itsbody.

FIG. 38 shows this latter configuration, where clip 110 has been foldedover by the combined action of piston foot 112 and fulcrum portion 118.Piston foot 112, pushed by piston, moves in direction F and pushes onpush points 128 of clip 110 until, as shown in FIG. 38, they are bent atan angle that lets the piston foot 112 slide by. At this point the clip114 is already deformed in the closed configuration with the tissuegrasping edges 132 firmly holding the tissue, but is still retainedwithin body 116 by fulcrum portions 118.

FIG. 39 shows one exemplary embodiment of how the deformed clip 110 canbe released from body 116. In this embodiment, the fulcrum portions 118can swing about a pivot point 140. In a first position, shown in FIG.38, the fulcrum portions 118 are in contact with hinge points 130, andprevent release of clip 110. In a second position, the fulcrum portions118 are rotated away from clip 110, and allow it to be released frombody 116. The clip 110 can be released by further movement of pistonfoot 112 in direction F, or simply by withdrawing deployment device 120once clip 110 is attached to the tissue.

In the embodiment described with reference to FIG. 39, the fulcrumportions 118 are moved between the first and second positions when asliding sleeve 122 has been actuated. Fulcrum portions 118 can beconnected by a linkage to sliding sleeve 122, so that movement of thesliding sleeve 122 causes pivoting of the fulcrum portions.Alternatively, fulcrum portions 118 can be biased in the secondposition, for example by a spring, and can be held in the first positionwhen covered by the sliding sleeve 122. Once sliding sleeve 122 is movedin direction F2, as shown in FIG. 39, fulcrum portions 118 are free tomove to the second position. Other known methods of connecting themovement of sliding sleeve 122, or of a similar element, to the pivotingof fulcrum portions 118 can be used, within the scope of the invention.

Sliding sleeve 122 can be operated in a variety of known manners. Forexample, a control cable 134 shown in FIG. 40 can be utilized. Thecontrol cable 134 can be connected to a control handle actuator 136outside the patient's body, so that the operator can extend and retractthe cable, thus moving the sliding sleeve 122 away and towards thefulcrum portions 118. Any other known method to operate a device at thedistal end of an endoscope could be used to achieve control of slidingsleeve 122, such as a pneumatic, mechanical or hydraulic control.

Piston and corresponding piston foot 112 can be operated, for example,by a fluid under pressure injected in the space 138 between the pistonand the body 116. Seals or O-rings can be used as necessary to preventleakage of the fluid from deployment device 120. The more fluid isinjected in space 138, the further piston moves in direction F. In oneembodiment, the fluid is provided by a tube 140 that connects thedeployment device 120 to a calibrated fluid force generator 142. Fluidforce generator 142 can be a manually operated piston, and can alsoinclude a force calibrating component, such as a calibrated valve, torelease fluid at a specified pressure. In one embodiment, the fluidforce generator is also placed outside the patient's body, near theproximal end of an endoscope 144.

As shown in FIG. 40, a syringe 148 or other similar device can beconnected to tube 140 to remove air from the line before the pressurizedfluid is injected. Since air is compressible, removing it results in amore accurate application of force to the piston.

Several different embodiments of the invention have been developed,having different fulcrum portions that assist in deforming the clip,hold the clip in place during deformation, and can be withdrawn torelease the clip. In one exemplary embodiment shown in FIG. 41, thefulcrum portion 150 is integral with the body 116′ of the device afterthe clip 110 is deformed in the closed configuration, continued movementof piston actuates cam surface 152 of fulcrum portion 150, so thatengaging portion 153 moves away from the clip 110. Clip 110 is thusreleased and can be ejected from body 116′ by further travel of piston114.

FIG. 42 shows another embodiment of the invention, where the fulcrums154 are moved by a cam surface of the sliding sleeve 122′. Slidingsleeve 122′ can be operated independently or in connection with piston114. As sliding sleeve 122′ moves in direction G, cam followers 156 offulcrum portions 154 are driven radially outward by cam surfaces 155. Inthis manner fulcrum portions 154 disengage clip 110 that is releasedfrom the device.

FIG. 43 shows an embodiment of the fulcrum portion that does not employa sliding sleeve. In this example, fulcrum portions 156 are integral tothe inside wall of body 116″, which can be preferably cylindrical.Fulcrum pistons 158 are used to move fulcrum portions 156 between thefirst and second position. In this example, fulcrum portions 156 arenormally in the open position, as show, where the clip is not engaged.Once the clip is loaded in the device, before being deformed, thefulcrum pistons 158 are activated and move downwards, so that fulcrumportions 156 engage clip 110. After clip 110 is deformed, the sequenceis reversed, and the clip is released.

FIG. 44 shows a different embodiment where the fulcrum portions 160 areformed on a detachable section 162 of body 116. In this example, afterpiston has deformed the clip 110, continued pressure by piston causesdetachable section 162 to separate, thus releasing the clip.

Alternatively, a portion of the clip 110 engaging the fulcrum portionscan be frangible, so that after the clip has been deformed, increasedforce from piston breaks the frangible portion, and releases the clip110 from the fulcrum portions. In the example shown in FIG. 45, hingepoints 130′ of the clip 110 incorporate a fissure 166, and a hole 164through which fits the fulcrum portion. After the clip 110 is deformed,additional pressure applied by the piston causes hinge point 130′ toseparate along fissure 166, and release clip 110 from the fulcrumportions.

In yet another embodiment shown in FIG. 46, the deployment deviceincludes gears 164 and racks 165, 166 that generate the force necessaryto deform and deploy clip 110. In this example, a clip carrier 168 holdsthe clip, and actuating cables 170 pull on the outer rack 165, which iscoupled to inner rack 166 by gears 164. As the cables 170 are actuated,linear motion in the outer gear rack 165 is transferred to the gears164. The gears 164, which are attached via their axles to the carrier168, are forced to rotate. The inner rack 166 transverses linearly alongthe carrier 168. In this embodiment, the inner rack 166 acts as themeans by which the clip could be formed and deployed. In effect, theinner rack 166 acts the same as the members 422 in FIG. 8, or as members112 in FIG. 38.

FIGS. 47 and 48 depict a different embodiment of the invention, wherethe fulcrum portions are integral with the clip 174. As the clip 174 isloaded into the endoscope cap, the fulcrums 172 are temporarily deformedfrom the state shown in FIG. 47, to the state shown in FIG. 48. Thisputs the fulcrums 172 in the necessary position so that the clip 174 canbe bent. After a force is applied (by a piston, or other means describedin this disclosure) to the clip 174 and the clip 174 is compressed ontothe tissue, the fulcrums 172 can be released. The fulcrums 172 need tobe released form the position shown in FIG. 48, and returned to theposition in FIG. 47 so that the clip 174 can be released from theendoscope cap.

In a different embodiment of the surgical clip according to theinvention, the clip is a multi legged clip (MLC) that includes a rigidring portion and a plurality of legs that are hinged to and extend fromthe ring portion. The legs can move between an open and a closedconfiguration, and in the closed configuration are designed to compressthe body tissue.

FIG. 49 shows one embodiment of the MLC 208 that includes a ring portion210 and multiple legs 212. A ratcheting mechanism 214 can be used tocontrol the position of the legs 212 relative to ring portion 210. Forexample, ratcheting mechanism 214 can allow legs 212 to move freely fromthe open to the closed position, but not in the opposite direction.

The movement can also be allowed in increments. As shown in FIG. 50, leg212 pivots on ring 210 through a hinge 216. Shaped notches 218 cooperatewith one end of legs 212 to form a ratchet that easily lets legs 212move from open position A to closed position C, in predefined steps, butdoes not allow the opposite movement.

The legs themselves can have different shapes. Changing the leg geometryand placement can change the force of the tissue compression, the arcswept by the MLC legs during closure, and the overall size of the areacompressed by the MLC. For example, thickening the cross section area ofthe leg or adding braces lengthwise, as shown in FIGS. 51 c and 51 dincreases the stiffness of the leg, as compared to the baselineconfiguration of FIG. 51 a. This results in a greater force ofcompression of the tissue. A tapered end of the legs, as shown in FIG.51 e leaves more space between the ends of the legs, so that more legscan fit in the MLC. However, this design would tend to compress thetissue with less force. FIGS. 51 a and 51 b depict different tips of thelegs, where the blunt end of FIG. 51 a tends to pinch more tissue, whilethe sharper end of FIG. 51 b tends to better grip the pinched tissue.

The MLC device 208 is deployed by an endoscope, while in the openposition, shown in FIG. 52, to the target site within the body. The legs212 are then moved to the closed position shown in FIG. 53 by thedeployment device after MLC 208 is positioned over the tissue to becompressed.

MLC 208 can be made of materials that have some level ofbiocompatibility. For example, the MLC can be made of polyethylene (highdensity, high or ultra high molecular weight), especially in a livinghinge design described below. Alternatively, the MLC can be made ofpolypropylene, of Teflon, which is very biocompatible and very rigid,and of polyurethane, which is also rigid. The more rigid the materialis, the more compression force the MLC can apply to the tissue. In adifferent exemplary embodiment, the ring portion 210 and the legs 212can be made of different materials, and metals such as stainless steeland titanium can be used for one or both components. Composite materialsand ceramics of implantable grade can also be used. Although thebiocompatibility of the material in the MLC has no bearing on themechanics of the device, when the MLC is used in a living body it shouldbe biocompatible as described above.

FIG. 54 shows an exemplary embodiment of a MLC and associated deliverydevice mounted on an endoscope. Delivery device 220 is mounted on thedistal end of endoscope 144, and includes the MLC 208, a retainingdevice 222, and the required actuators. The body of the MLC 208 isformed by ring portion 210, which can fit around the outer diameter ofendoscope 144. A retaining device 222 can be used to prevent MLC 208from sliding off, and can include a movable catch. Once MLC 208 isdeployed, the catch is retracted, and the MLC 208 can slide off the endof endoscope 144.

An exemplary embodiment of an actuator for the legs 212 of MLC 208 isshown in FIG. 55. In this embodiment, the legs 212 are connected attheir tips with cables 224, that run along the endoscope to the proximalportion of endoscope 144. The operator can thus close legs 212 aroundthe tissue to be compressed simply by pulling on cables 224.

A second embodiment of the actuating mechanism is shown in FIG. 56. Inthis example, a pinion gear 226 is rotated remotely, for example bypulling a string 229 attached to the axis of pinion gear 226. String 229can also run through endoscope 144. Rotation of pinion 226 causes rack228 to move, and in turn causes legs 212 to close around the tissue.

Alternatively, the legs 212 can be actuated by a resilient device suchas spring 230, which can be a torsional spring shown in FIG. 57. Spring230 is attached to the ring portion 210, and applies a force on legs 212to place them in the closed configuration. Any known method of keepingthe legs 212 in the open configuration can be used until the MLC 208 isin position over the tissue to be compressed. Once released, the spring230 of MLC 208 closes legs 212 over the tissue.

In a different embodiment, an outer sheath 232 can be slidably placedover the endoscope 144. In a retracted position, shown in the firstframe of FIG. 58, the sheath 232 does not interfere with legs 212, thatare in the open configuration. When sheath 232 is pushed to an extendedposition, shown in the second frame of FIG. 58, it forces legs 212 toclose, thus compressing the tissue placed between legs 212.

In yet another example of deployment mechanism, shown in FIG. 59, one ormore pistons 234 are used to push on the upper portion of legs 212, thusforcing them in the closed configuration. Pistons 234 can be operated,for example, by fluid such as saline injected through a cylinder 236that extends from the proximal to the distal end of endoscope 144.

FIG. 60 shown an embodiment of a release mechanism to separate the MLC208 from the delivery device 220. In this example, stitches 238 areformed between the upper edge of MLC 212 and the lower lip of thedelivery device 220. Stitches 238 are formed by string 240, which hasone end that travels along the endoscope 144 to the proximal end. Afterlegs 212 have been closed to compress the tissue, string 240 is pulledat the proximal end of endoscope 144, so that stitches 238 unravel, andMLC 212 is released from delivery device 220.

A different embodiment of the release mechanism is shown in FIG. 61. Inthis case, an elastomeric seal 242 attaches the ring portion 210 of MLC208 to the lower end of delivery device 220. After MLC 208 is deployed,string 240′ is pulled from the proximal end of endoscope 144, and, as itis pulled, cuts through elastomeric seal 242, releasing MLC 208.

Alternative embodiments of the release mechanism are shown in FIGS. 62,63 and 64. In the example of FIG. 62, a snap fit is formed betweenshaped protrusion 244 extending from ring portion 210 and acorresponding groove 245 formed in delivery device 220. Once the MLC 208is closed around the tissue, a force can be applied to MLC 208 todisengage it from the delivery device 220. For example, the force can beapplied by the same piston 234 used to close legs 212, or by anyarrangement of wires or separate pistons operable from the proximal endof endoscope 144.

FIG. 63 shows a different catch configuration, where a catch 246extending from ring portion 210 engages a groove 248 formed in deliverydevice 220. After MLC 208 is attached to the tissue, piston 234′deflects catch 246 away from groove 248, thus releasing MLC 208 from thedelivery device. Piston 234′ can be the same piston that closes legs212, or a separate piston. Alternatively, catch 246′ can be formed onthe delivery device 220 and groove 248′ can be formed in ring portion210, as shown in FIG. 64. A piston or sheath 250 can then be moved todisengage catch 246′ from groove 248′.

The design of the hinges between legs 212 and ring portion 210 affectsboth the function and the manufacturing methods for the MLC 208. Inembodiments where the legs 212 and the ring portion 210 are formed ofone piece, the connection will be a “living hinge” as shown in FIG. 66.This configuration requires a more complex mold, but simplifies theassembly step. In addition, the legs 212 can be molded such that theyare naturally in the open position, simplifying deployment.

Depending on the position of the legs, the hinge can be positionedeither on top or on the bottom edge of ring portion 210. As shown inFIG. 65, when legs 212 are placed outside of ring portion 210, the hinge216′ is preferably located on the top edge. If the legs 212 are placedinside of ring 210, as shown in FIG. 66, hinge 216 is preferably on thelower edge of ring portion 210.

In a different exemplary embodiment shown in FIG. 67, the living hingeis replaced by a pin joint. In this example, pins 252 are formed in leg212, and pin receiving holes 254 are formed in ring portion 210. Theopposite configuration can also be used, with the pins extending fromring portion 210. When a pin configuration is used, the legs 212 andring portion 210 can be made separately, possibly of differentmaterials. However, it may be necessary to use a hinge or spring to urgethe legs in either the closed or open configuration for ease ofinsertion. For example, a latch 256 is shown in FIG. 68 to maintain legs212 in the open configuration.

In a different embodiment, a four bar mechanism can be used to attachlegs 212 to ring portion 210. As shown in FIG. 69, the upper and lowerbars 258, 260 allow legs 212 to pivot and tilt inward to the closedposition. Any of the actuating mechanisms discussed above can be used tooperate the four bar hinge, such as cables, gears or pistons.

Various design of the snap fit mechanism used to control pivotalmovement of the legs can be used within the scope of the invention. Thedesign of the snap fit permits to tailor the closed position of thelegs, and the force exerted by the legs on the compressed tissue. FIG.66 shows a snap fit 262 having several snaps 264 that engage the topportion of leg 212. This design keeps the interference between the legs212 and the snap fit 262 to remain constant as the legs close. It alsoallows for more legs to be fit on MLC 208, thus permitting greatervariability of compressive force being applied.

FIG. 70 shows a similar arrangement, but with the snap fits 262′engaging the leg 212 on the sides rather than the top portion. In thiscase, each snap 264′ can be larger than the other, increasing thecompression force by increasing the interference between leg 212 andring portion 210.

As shown in FIG. 71, snap fits 266 can be used in the hinges of a fourbar mechanism, instead of between the leg 212 and the ring portion 210.This design allows separation and control of the vertical and angularmotion of the legs relative the ring.

The ratchet design can also be reversed, with the ratchet teeth beingformed on the legs. For example, as shown in FIG. 72, leg 212 can have aratchet 269 that cooperates with a spring loaded pawl 270 mounted onring portion 210. In this manner, it is possible to mount more legs onthe MLC 208, giving more flexibility in compressing the tissue.

It is apparent to one of ordinary skill in the art that the variousembodiments for components of the invention described herein can bematched as required for the specific applications, while remainingwithin the scope of the invention.

The present invention may be utilized for any of a variety of differentapplications and surgical procedures. Whereas the present invention maybe utilized in endoscopic techniques for clipping bleeding, orpotentially bleeding, peptic ulcers, either gastric or duodenal, otheruses of the present invention are contemplated. For example, the presentinvention can be utilized for all hemorrhaging, or potentiallyhemorrhaging, gastro-intestinal lesions. These include all of theindications presently known for the traditional treatments. A partiallist includes:

Esophageal Varices and ulcers

Mallory-Weiss Tears

Gastric erosions

Esophagitis

Erosive Duodenitis

Tumors

Angiodysplasia

Bleeding polyp stalks

Diverticular Bleeding

Other endoscopic indications could be developed for clinically inducedwounds. A representative list which is not intended to be all inclusiveincludes:

Laparoscopic repair of Gall Bladder perforation during Cholecystectomy

Repair of perforations to biopsy or mucosectomy

Repair of excessive bleeding due to biopsy or mucosectomy

Repair of incomplete resections

Closing of induced wounds to gain access through GI lumens into otheranatomical areas like the outside of the gall bladder, liver, andpancreas

Colonic perforation related to colonoscopy

There are also vascular applications for the surgical clip and deliverysystem. Miniaturization of the surgical clip and the delivery systemcould permit vascular repair. Visualization could be either direct,radiograph, MRI or sonic. The applications are for minimally invasivesurgery, aneurysm repair and graph/implant attachment.

Again, as discussed above, the present invention could be utilized forany of a variety of procedures, including to close an organ perforationfrom inside a lumen by approximating and compressing the wound edges ofthe perforated tissue.

The disclosed embodiments are illustrative of the various ways in whichthe present invention may be practiced. Other embodiments can beimplemented by those skilled in the art without departing from thespirit and scope of the present invention.

1. A device for endoscopically deploying a hemostatic clip adapted tograsp tissue in a deformed configuration, comprising: a body adapted tofit on a distal end of an endoscope and to contain the clip; a fulcrumportion cooperating with the body and the clip, the fulcrum portionhaving a first position in contact with hinge points of the clip and asecond position releasing the clip from the body; and an actuatorexerting a force on push points of the clip to deform the clip, wherein,in the first position, the fulcrum portion retains the clip against theforce exerted by the actuator to facilitate deformation of the clipwherein the fulcrum portion retains the clip in the body when in thefirst position.
 2. The device according to claim 1, wherein the actuatorejects the clip from the body after deformation.
 3. The device accordingto claim 1, further comprising a second actuator to move the fulcrumportion between the first and second positions.
 4. The device accordingto claim 3, wherein the actuator and second actuator are linked.
 5. Thedevice according to claim 3, wherein the actuator and second actuatorare integrally formed.
 6. The device according to claim 1, wherein theactuator comprises at least a piston pushing the push points of theclip.
 7. The device according to claim 6, wherein the piston is actuatedhydraulically.
 8. The device according to claim 1, wherein thehemostatic clip is adapted to deform about the hinge points.
 9. Thedevice according to claim 8, wherein the clip is substantially ringshaped.
 10. The device according to claim 9, wherein the clip comprisesa serrated tissue grasping edge.
 11. The device according to claim 1,wherein the fulcrum portions extend from the hinge points of the clip.12. The device according to claim 11, wherein the fulcrum portions aredeformable when subject to a force greater than a deformation force ofthe clip.
 13. The device according to claim 1, wherein the fulcrumportion is formed to resiliently retain one of the first and secondpositions.
 14. A device for endoscopically deploying a hemostatic clipadapted to grasp tissue in a deformed configuration, comprising: a bodyadapted to fit on a distal end of an endoscope and to contain the clip;a fulcrum portion cooperating with the body and the clip, the fulcrumportion having a first position in contact with hinge points of the clipand a second position releasing the clip from the body; an actuatorexerting a force on push points of the clip to deform the clip, wherein,in the first position, the fulcrum portion retains the clip against theforce exerted by the actuator to facilitate deformation of the clip; andfurther comprising a second actuator to move the fulcrum portion betweenthe first and second positions wherein the second actuator is a slidingsleeve actuated by a cable.
 15. A device for endoscopically deploying ahemostatic clip adapted to grasp tissue in a deformed configuration,comprising: a body adapted to fit on a distal end of an endoscope and tocontain the clip; a fulcrum portion cooperating with the body and theclip, the fulcrum portion having a first position in contact with hingepoints of the clip and a second position releasing the clip from thebody; and an actuator exerting a force on push points of the clip todeform the clip, wherein, in the first position, the fulcrum portionretains the clip against the force exerted by the actuator to facilitatedeformation of the clip wherein the clip comprises two push points andtwo hinge points alternating along a circumference of the clip.
 16. Adevice for endoscopically deploying a hemostatic clip adapted to grasptissue in a deformed configuration, comprising: a body adapted to fit ona distal end of an endoscope and to contain the clip; a fulcrum portioncooperating with the body and the clip, the fulcrum portion having afirst position in contact with hinge points of the clip and a secondposition releasing the clip from the body; an actuator exerting a forceon push points of the clip to deform the clip, wherein, in the firstposition, the fulcrum portion retains the clip against the force exertedby the actuator to facilitate deformation of the clip wherein thefulcrum portion is formed to resiliently retain one of the first andsecond positions; and, further comprising a removable retainer toselectively retain the fulcrum portion in the other of the first andsecond position.
 17. A device for endoscopically deploying a hemostaticclip adapted to grasp tissue in a deformed configuration, comprising: abody adapted to fit on a distal end of an endoscope and to contain theclip; a fulcrum portion cooperating with the body and the clip, thefulcrum portion having a first position in contact with hinge points ofthe clip and a second position releasing the clip from the body; anactuator exerting a force on push points of the clip to deform the clip,wherein, in the first position, the fulcrum portion retains the clipagainst the force exerted by the actuator to facilitate deformation ofthe clip; and, further comprising a second actuator to move the fulcrumportion between the first and second positions wherein the fulcrumportion is attached to the sliding sleeve.
 18. The device according toclaim 17, wherein the fulcrum portion moves along cam surfaces of thesliding sleeve.
 19. A device for endoscopically deploying a hemostaticclip adapted to grasp tissue in a deformed configuration, comprising: abody adapted to fit on a distal end of an endoscope and to contain theclip; a fulcrum portion cooperating with the body and the clip, thefulcrum portion having a first position in contact with hinge points ofthe clip and a second position releasing the clip from the body; and anactuator exerting a force on push points of the clip to deform the clip,wherein, in the first position, the fulcrum portion retains the clipagainst the force exerted by the actuator to facilitate deformation ofthe clip further comprising protrusions axially extending along thebody.